Breakyl: first buccal film formulation of fentanyl launched

Meda Pharmaceuticals has launched Breakyl, a buccal film which contains fentanyl and is licensed for the treatment of breakthrough pain in opioid therapy for chronic cancer pain.

If more than one film is required per dose, the Breakyl films should ideally be placed on opposite sides of the buccal mucosa to avoid overlap and ensure full absorption of drug from each film.

The product consists of a small rectangular dissolvable film with a pink side that contains fentanyl and a white side which has been designed to minimise fentanyl release into the saliva to avoid swallowing of the active substance. The patient should moisten the inside of the cheek with saliva or by rinsing with water and then press the pink side of the film against the inside of the cheek for a minimum of 5 seconds. The film should adhere and stay in place for 15 to 30 minutes until it has dissolved completely.

The recommended initial dose of Breakyl is 200 microgram, titrated upwards as necessary. Each dose of Breakyl must be separated by at least 4 hours; if adequate pain relief is not observed, alternative rescue medication can be administered and the next highest strength of Breakyl should be administered for the next episode of breakthrough pain.